A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension (HM_APOLLO)

Hanmi Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: Losartan; Drug: HCP1803; Drug: Placebo; Drug: Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03897868

HM-APOLLO-201

Details and patient eligibility

About

A multicenter, randomized, double-blind, parallel, phase 2 study to assess dose-response relationship of HCP1803 in patients with essential hypertension

Enrollment: 248 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and mean sitDBP < 110 mmHg at Visit 1, Visit 2

Exclusion criteria

• Patient with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
• Patient with difference of ≥ 15 mmHg in mean sitSBP between Visit 1 and Visit 2
• Patient with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg at Visit 1, Visit 2
• Patient with secondary hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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248 participants in 7 patient groups, including a placebo group

Experimental 1

Experimental group

Description:

HCP1803 High

Treatment:

Drug: Placebo

Drug: HCP1803

Experimental 2

Experimental group

Description:

HCP1803 Middle

Treatment:

Drug: Placebo

Drug: HCP1803

Experimental 3

Experimental group

Description:

HCP1803 Low

Treatment:

Drug: Placebo

Drug: HCP1803

Active Comparator 1

Active Comparator group

Description:

HGP0904 High

Treatment:

Drug: Amlodipine

Active Comparator 2

Active Comparator group

Description:

HGP0904 Low

Treatment:

Drug: Placebo

Drug: Amlodipine

Active Comparator 3

Active Comparator group

Description:

HGP0608

Treatment:

Drug: Placebo

Drug: Losartan

Placebo Comparator

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo